Quality Engineer - Validation

Validation Engineer - Contract | Medical Device Manufacturer | North Carolina (Hybrid)

A leading medical device manufacturer in North Carolina is seeking a Validation Engineer for a contract position to support product development, validation, and quality assurance initiatives.

Position Summary:
This role applies quality engineering principles across all phases of the product lifecycle, including planning, development, and qualification/validation. The successful candidate will contribute to the deployment of quality strategies and ensure compliance with internal and external standards.

Key Responsibilities:

• Lead validation activities including protocol development and execution (IQ/OQ/PQ).
• Support new product launches using APQP methodologies.
• Analyze process and product performance data to assess capability and compliance.
• Collaborate with cross-functional teams to optimize manufacturing processes.
• Develop validation documentation in accordance with internal and customer requirements.
• Manage multiple programs and customer deliverables simultaneously.

Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 3 years of experience in a similar role, preferably in medical or pharmaceutical manufacturing.
• Proficient in validation processes and statistical analysis (Minitab preferred).
• Experience with plastic injection molding and GD&T (ASME Y14.5) is desirable.
• Strong analytical, communication, and project management skills.

Additional Skills:

• Knowledge of measurement system analysis (MSA/GR&R).
• Familiarity with quality assurance tools and time management practices.
• Ability to work independently and collaboratively in a fast-paced environment.